NO_LONGER_AVAILABLENot Applicable

HEMOLEVEN® Expanded Access Program Prevention of Surgical/Postpartum Hemorrhage Severe Inherited Factor XI Deficiency

United States

Plain-language summary

The objective of the Expanded Access Program is to provide HEMOLEVEN, a replacement coagulation factor XI, to patients with severe inherited factor XI deficiency where, in the opinion of the treating physician, the benefits of administering selectively the missing factor outweigh the potential risks associated with the administration of fresh-frozen plasma.

Who can participate

Age range6 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Severe inherited factor XI deficiency (FXI:C \< 0.20 IU/mL i.e. \<20 %)
✓. Patient older than 6 months old and weight at least 8 kg
✓. Known personal bleeding history
✓. Patient requiring FXI replacement therapy when oral antifibrinolytic agents alone or other means are ineffective or are contraindicated
✓. Scheduled to undergo an elective surgical procedure (including caesarean section) for which the patient requires hemostasis prophylaxis, which in the case of caesarean section is due to a history of postpartum bleeding, OR vaginal delivery for which the patient requires hemostasis prophylaxis due to a history of postpartum hemorrhage
✓. Patient/guardian provides signed and dated Informed Consent for 'HEMOLEVEN Expanded Access Program' prior to entry into the program

Exclusion criteria

✕. Personal history of thromboembolic events
✕. Underlying cardiopulmonary disease of NYHA Class III or greater
✕. History of severe reaction to any component of HEMOLEVEN notably to heparin or to its derivatives,including LMWH. Past history of serious type II heparin-induced thrombocytopenia (HIT)
✕. Presence of antibody to FXI in the past or currently
✕. Presence of any other condition that could contraindicate treatment with factor XI concentrate or lead the Physician/Investigator to believe treatment would not be in the best interest of the patient
✕. Positive, confirmed pregnancy test for patients undergoing elective surgery (not applicable for caesarean section and prevention in vaginal delivery)
✕. Lactating woman.

Trial details

NCT IDNCT01701947

SponsorLaboratoire français de Fractionnement et de Biotechnologies

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

View on ClinicalTrials.gov More Wound; Rupture, Surgery, Cesarean Section trials